BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUADROX-I

    MDR report key: 2379574 · Received November 17, 2011

    Report

    Report Number
    8010762-2011-00017
    Event Type
    Other
    Date Received
    November 17, 2011
    Date of Event
    November 4, 2011
    Report Date
    November 8, 2011
    Manufacturer
    HAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOVASCULAR US SALES LLC SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MFR OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). THE SAMPLE IS BEING REQUESTED. THE SAMPLE IS PENDING RETURN/EVAL. ITEMS MARKED NI ARE UNK TO US AT THIS TIME. MFR REFERENCE NUMBER: (B)(4). UF/IMPORTER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    WHILE ON CPB THE CCP DECIDED TO CONNECT THE DIALYSIS LOCK AND VALVE PORT OF THE QUADROX-I TO THE HEMOCONCENTRATOR- HE ATTACHED THE (B)(4) ADAPTER VKMO/LINE TO THE VALVE PORT WITH A SWIFT TURN-AND-PRESS MOTION, HOWEVER THE ROBERTS CLAMP WAS CLOSED- THE RESULT WAS SPRAY OF BLOOD AND A PULSATING BACKFLOW OF AIR INTO THE OXYGENATOR AND OUT OF THE ARTERIAL OUTLET SIDE. THE BUBBLE DETECTOR ALARMED AND SHUT THE PUMP OFF- THE CCP OVERRODE THE BUBBLE DETECTOR, RESET THE PUMP AND AS FORWARD FLOW BEGAN, THE SAME SITUATION HAPPENED. THIS HAPPENED 3 MORE TIMES, FINALLY THEY USED THE ROTAFLOW HAND-CRANK, FOR APPROX 1-2 MINS AND SET THE PUMP IN A FREE MODE TO OVERRIDE THE ALARMS AND SHUT-OFF. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADROX-I OXYGENATOR DTZ HAQUET CARDIOPULMONARY AG VKMO 70000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI